Sr. Director, CMC Project Management

CMC Project Planning & Strategy

• Support the SVP of Technical Operations and CMC functional leads to developing and maintain integrated CMC development plans aligned with overall program and corporate objectives.
• Develop and maintain integrated CMC project plans, complex timelines and Gantt charts covering process and analytical development, manufacturing, stability study, regulatory CMC deliverables, clinical supply, and other Technical Operations activities. Establish appropriate links and dependencies between activities and identify critical-path activities.

• Track CMC activities, milestones, deliverables, dependencies, and commitments against approved project plans.
• Track decisions, risks, issues, and changes to project scope or timelines. Proactively identify schedule risks, resource constraints, dependencies, and potential delays and escalate issues to the SVP of Technical Operations and appropriate functional leads.
• Maintain project dashboards and provide concise, accurate status updates to management and project teams.

CMC Team Coordination & Meetings

• Plan, organize meeting agendas, and facilitate internal CMC/Technical Operations meetings.
• Prepare clear and concise meeting minutes documenting key discussions, decisions, action items, owners, and due dates.
• Maintain and actively manage action-item and decision logs. Follow up with responsible parties to ensure timely closure of action items.

Cross-Functional Collaboration

• Serve as a central project-management interface between Technical Operations/CMC and functions including Clinical, Regulatory, Quality, Finance, Legal, and Program Management.
• Coordinate CMC timelines with overall clinical and regulatory development plans.
• Support effective communication and information flow across CMC/Technical Operations functions and cross-functional project teams.
• Support Technical Operations leadership in portfolio planning, management reporting, and preparation for executive-level reviews.

Budget, Contract & Invoice, CMC Documentation & Information Management

• Develop and maintain detailed CMC project budgets and forecasts in collaboration with the SVP of Technical Operations and CMC functional leads.
• Review and track vendor/CDMO invoices against contracts, statements of work, purchase orders, milestones, and agreed payment schedules.
• Maintain accurate financial trackers for CMC programs and external vendor activities.
• Support annual budget planning, reforecasting, and long-range CMC financial planning.
• Establish and maintain a well-organized CMC electronic filing and document-management structure.
• Organize CMC SharePoint folders and maintain appropriate filing conventions for project plans, development reports, manufacturing documents, analytical documents, stability information, regulatory documents, contracts, meeting records, budgets, and vendor documentation.